The goal of this clinical trial is to investigate the effects of a perioperative multimodal rehabilitation program on the incidence of postoperative complications and perioperative clinical indexes including functional capacity, nutritional and psychological status in patients with gastric cancer undergoing neoadjuvant therapy. Besides the investigators also develop a smart phone based digital platform aiming to evaluate its effectiveness in improving patient adherence, compared with the conventional telephone supervision approach. The main questions it aims to answer are: * Can the perioperative multimodal rehabilitation program reduce postoperative complications in patients with gastric cancer undergoing neoadjuvant therapy? * Can the smart phone based digital platform improve patients' adherence compared to traditional telephone supervision? * Can the perioperative multimodal rehabilitation program improve the perioperative clinical indicators of patients with gastric cancer undergoing neoadjuvant therapy, including functional capacity, nutritional status and psychological condition? The investigators will compare the perioperative multimodal rehabilitation program with the standard treatment alone to determine whether this program has the effects mentioned above. Participants will follow the perioperative multimodal rehabilitation program from neoadjuvant therapy through to four weeks after discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
The perioperative rehabilitation program in this study constitutes a multimodal intervention that integrates exercise, nutrition, and psychological support. The exercise component consists of aerobic training five times per week, elastic band-based resistance training twice per week, daily respiratory muscle exercises, and post-exercise stretching routines. For nutrition, daily targets are set at 25-30 kcal/kg for energy and 1.5 g/kg for protein intake based on ideal body weight, supported by standardized meal plans and nutritional reference materials. The psychological intervention includes weekly motivational videos and psychoeducational content, supplemented by regular assessment of emotional and cognitive status using validated scales. Patients independently follow the program, and record all activities in a rehabilitation diary, which will be returned post-trial.Additionally, patients will receive a weekly telephone call, to assess adherence to the program.
Patients receive usual care throughout their cancer pathway. Besides, we will provide verbal exercise, dietary, and psychological advice to patients but did not provide written advice and supervision.
The perioperative rehabilitation program in this study constitutes a multimodal intervention that integrates exercise, nutrition, and psychological support. The exercise component consists of aerobic training five times per week, elastic band-based resistance training twice per week, daily respiratory muscle exercises, and post-exercise stretching routines. For nutrition, daily targets are set at 25-30 kcal/kg for energy and 1.5 g/kg for protein intake based on ideal body weight, supported by standardized meal plans and nutritional reference materials. The psychological intervention includes weekly motivational videos and psychoeducational content, supplemented by regular assessment of emotional and cognitive status using validated scales. The digital platform provides personalized exercise videos, nutritional logging tools, and psychological modules. Researchers monitor engagement metrics weekly to guide adjustments.
Beijing Friendship Hospital, Capital Medical University
Beijing, China
RECRUITINGComplications at 90 days after surgery
The primary outcome of the study is the postoperative morbidity rate by the Clavien-Dindo classification at 90 days postoperatively. All postoperative complications will be documented at discharge and the surgeon will record any events after discharge at the outpatient appointment 90 days postoperatively. All complications will be classified by the Clavien-Dindo classification.
Time frame: From the time of the surgery to 90 days postoperatively
Adherence--(1)Assessment completion rate
In the telephone therapeutic group , patients use a rehabilitation diary to report their progress throughout the perioperative multimodal rehabilitation program. Besides, adherence is additionally assessed by researchers through a structured adherence assessment form during the scheduled weekly calls. In the digital therapeutic group, all completion data are recorded directly by the digital platform. It is measured by the completion status of the adherence assessment form or the completion data recorded by the digital platform.
Time frame: From enrollment to 4 weeks after discharge
Adherence--(2)The mean number of training sessions attended
Time frame: From enrollment to 4 weeks after discharge
Adherence--(3)The number of patients requiring exercise intensity adjustment
Time frame: From enrollment to 4 weeks after discharge
Adherence--(4)The number of patients requiring early termination of the intervention
Time frame: From enrollment to 4 weeks after discharge
Adherence--(5)The number of patients who permanently discontinued the training
Time frame: From enrollment to 4 weeks after discharge
Adherence--(6)The number of patients lost to follow-up
Time frame: From enrollment to 4 weeks after discharge
Short-term safety--(1)Incidence of adverse events during the study
Time frame: From enrollment to 4 weeks after discharge
Short-term safety--(2) Postoperative in-hospital mortality rate
Time frame: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Short-term safety--(3) 90-day postoperative mortality rate
Time frame: From the time of surgery to 90-day postoperative
Short-term safety--(4)Postoperative in-hospital morbidity rate
Time frame: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Short-term safety--(5) 30-day postoperative morbidity rate
Time frame: From the time of surgery to 30-day postoperative
Short-term safety--(6) Morbidity rate during neoadjuvant therapy
Time frame: From start of neoadjuvant treatment to end of neoadjuvant treatment, assessed up to 100 days
The quality of life--(1) EORTC-QLQ-C30
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC-QLQ-C30) includes 30 items measuring functional, symptomatic, and global quality-of-life domains.Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.
Time frame: From enrollment to 1 year postoperatively
The quality of life--(2) EORTC-QLQ-STO22
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Module 22(EORTC-QLQ-STO22) supplement contains 22 items assessing symptoms and concerns specific to gastric cancer. Scores are transformed to a 0-100 scale, with higher scores indicating greater symptom burden.
Time frame: From enrollment to 1 year postoperatively
The quality of life--(3)PGSAS-45
The Postgastrectomy Syndrome Assessment Scale 45(PGSAS-45), consisting of 45 items, will be used to comprehensively evaluate postgastrectomy symptoms, digestive status, and daily life functions.All subscale scores are linearly transformed to a 0-100 range. For symptom-related subscales, higher scores indicate greater symptom burden; for functional and quality of life subscales, higher scores indicate better functioning or quality of life.
Time frame: From the time of surgery to 1 year postoperatively
Functional capacity--(1) The sit to stand test
Participants will sit on a standard-height chair (43-45 cm) with arms crossed over the chest, feet flat on the floor placed shoulder-width apart and parallel. They will then complete 10 repetitions of standing up and sitting down as quickly as possible, ensuring full knee extension upon each stand. The time to complete 10 repetitions will be recorded. Each participant will perform two trials, and the best time will be recorded.
Time frame: From enrollment to 1 year postoperatively
Functional capacity--(2) The handgrip strength
The handgrip strength test will be administered using a digital hand dynamometer. Participants will stand with the dominant upper arm held firmly against the trunk and the forearm positioned at a 90-degree angle. The gripping handle will be adjusted to a comfortable width, allowing the fat pads of the four fingers to rest securely on the handle. Participants will be instructed to squeeze the handle with maximum effort for 3 seconds. Each participant will perform three trials with adequate rest between attempts, and the average value will be recorded.
Time frame: From enrollment to 1 year postoperatively
Functional capacity--(3) Peak oxygen consumption (VO₂ peak)
The indicator will be assessed by cardiopulmonary exercise test (CPET)
Time frame: From enrollment to 1 year postoperatively
Functional capacity--(4) anaerobic threshold (AT)
The indicator will be assessed by cardiopulmonary exercise test (CPET)
Time frame: From enrollment to 1 year postoperatively
Functional capacity--(5) 6-minute walk test(6MWT)
The 6MWT is conducted along a 20 meter course marked by cones. Participants are instructed to walk back and forth as far as possible within 6 minutes, and the total distance walked (calculated from the number of laps) is recorded. The test is administered following the standardized instructions recommended by the European Respiratory Society.
Time frame: From enrollment to 1 year postoperatively
Functional capacity--(6) Frailty
Frailty will be assessed according to the Fried Frailty Phenotype, which comprises five components: shrinking, exhaustion, weakness, slowness, and low physical activity. Participants meeting three or more criteria will be classified as "frail"; those meeting one or two criteria will be classified as "pre frail"; and those meeting none will be classified as "robust/non frail".
Time frame: From enrollment to 1 year postoperatively
Nutritional status--(1) BMI
It is calculated in the standard manner as weight in kilograms divided by height in meters squared (kg/m²).
Time frame: From enrollment to 1 year postoperatively
Nutritional status--(2)skeletal muscle index(SMI)
As part of standard care, patients undergo CT imaging at baseline, following neoadjuvant therapy, and during postoperative follow-up. Sarcopenia is measured at these time points using ImageJ software. At the L3 level, total skeletal muscle, subcutaneous fat and visceral fat will be measured. SMI will be calculated as follows: skeletal muscle /height(m)2. Measurements will be recorded by two individuals, one of whom will be external to the trial group.
Time frame: From enrollment to 1 year postoperatively
Nutritional status--(3)mid-upper arm circumference(MUAC)
Patients stand upright with shoulders relaxed and the right arm hanging naturally. The assessor, positions to the participant's right, wraps a measuring tape around the midpoint between the acromion and olecranon processes, ensuring it remains perpendicular to the long axis of the arm. The tape is held snug but without compressing the underlying soft tissue. The measurement is taken on the lateral aspect of the arm, with the zero end of the tape aligned under the measurement mark.
Time frame: From enrollment to 1 year postoperatively
Nutritional status--(4)triceps skinfold thickness(TSF)
TSF is measured at the same marked midpoint on the right upper arm as MUAC. With the patients standing, a vertical skinfold parallel to the arm is gently grasped above the mark. A caliper is applied perpendicular to the fold, and the thickness is recorded to the nearest 0.1 mm before release.
Time frame: From enrollment to 1 year postoperatively
Nutritional status--(5)insulin resistance(IR)
IR will be measured using the homeostasis model assessment(HOMA) calculation. HOMA-IR = (fasting glucose × fasting insulin) / 22.5.
Time frame: From enrollment to 1 year postoperatively
Nutritional status--(6)Hemoglobin level
Time frame: From enrollment to 1 year postoperatively
Nutritional status--(7)Prealbumin level
Time frame: From enrollment to 1 year postoperatively
Nutritional status--(8)Total cholesterol level
Time frame: From enrollment to 1 year postoperatively
Nutritional status--(9)Serum albumin level
Time frame: From enrollment to 1 year postoperatively
Nutritional status--(10)Total lymphocyte count
Time frame: From enrollment to 1 year postoperatively
Nutritional status--(11)Inflammatory marker
It will be measured by serum C reactive protein (CRP) level.
Time frame: From enrollment to 1 year postoperatively
Nutritional status--(12)Glasgow Prognostic Score (GPS)
It is a combined score based on CRP and serum albumin level. Scores range from 0 to 2, with higher scores indicating greater systemic inflammation and poorer prognosis.
Time frame: From enrollment to 1 year postoperatively
Nutritional status--(13)prognostic nutritional index(PNI)
It is a combined score based on serum albumin level and total lymphocyte count. It is calculated as 10 × serum albumin (g/dL) + 0.005 × total lymphocyte count (cells/μL). Higher scores indicate better nutritional and immunological status.
Time frame: From enrollment to 1 year postoperatively
Psychological scale scores--(1)Hospital Anxiety and Depression Scale (HADS)
It is a 14 item self report instrument comprising two 7 item subscales designed to screen for symptoms of anxiety and depression in non psychiatric medical settings. Each subscale is scored separately, providing independent measures of anxiety and depressive symptomatology while minimizing confounding from physical illness. Each item is scored from 0 to 3, with subscale scores ranging from 0 to 21. Higher scores indicate greater levels of anxiety or depression. The scale has been validated and demonstrates good reliability in clinical populations.
Time frame: From enrollment to 1 year postoperatively
Psychological scale scores--(2)Life Orientation Test Revised (LOT-R)
It comprises 10 items evaluating an individual's expectancies for positive versus negative future experiences. Each item is scored on a 5-point scale (0-4). After reverse-scoring pessimism items, total scores range from 0 to 24, with higher scores indicating greater optimism.
Time frame: From enrollment to 1 year postoperatively
Psychological scale scores--(3)General Self Efficacy Scale (GSE)
It is a 10-item psychometric instrument designed to assess optimistic self-beliefs in one's ability to cope with a wide range of difficult life demands. It is a well-validated and highly reliable measure of generalized self-efficacy. Each item is scored on a 4-point scale (1-4). Total scores range from 10 to 40, with higher scores indicating greater self-efficacy.
Time frame: From enrollment to 1 year postoperatively
Psychological scale scores--(4)EuroQol 5 Dimension 5 Level (EQ-5D-5L)
It is a standardized, generic instrument developed by the EuroQoL Group to measure health status. It provides a concise profile of health outcomes designed for use in both clinical studies and health economic evaluations. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises five levels of perceived problems, ranging from no problems to extreme problems. Responses are summarized as a five-digit health profile, which can be converted into a utility index score, typically ranging from 0 to 1, with higher scores indicating better health status.
Time frame: From enrollment to 1 year postoperatively
Psychological scale scores--(5)Pearlin Mastery Scale (PMS)
It is a 7-item scale developed to measure psychological coping resources, specifically an individual's sense of mastery or perceived control over life circumstances. It is also a validated and reliable tool. Each item is scored on a 4-point scale (1-4). Total scores range from 7 to 28, with higher scores indicating greater perceived mastery or sense of control.
Time frame: From enrollment to 1 year postoperatively
Psychological scale scores--(6)Surgical Fear Questionnaire (SFQ)
It is an eight-item instrument designed to assess fear related to surgery. It consists of two subscales measuring fear of short-term and long-term surgical consequences, and has been validated as a reliable index of surgical fear. Each item is scored on an 11-point scale (0-10). Subscale scores range from 0 to 40, and total scores range from 0 to 80. Higher scores indicate greater surgical fear.
Time frame: From enrollment to the day before surgery, assessed up to 100 days
Gastric emptying function
It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy.
Time frame: From the time of surgery to 90-day postoperative
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